MiniMed® 530G MMT-551PNALRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169507289), received between Jun 28, 2017 and Feb 5, 2020 — classified as 8 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (P120010); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER REPORTED THAT SHE INSERTED IN A NEW RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9669354 ↗
• MalfunctionDec 4, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414526 ↗
• MalfunctionNov 25, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS STOPPED DURING REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD DECREASED BATTERY LIFE, DISPLAY SCREEN CRACKED, SOFTENER WHEN REWINDING NOT LOUDER, SCRATCHES ON SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9373747 ↗
• MalfunctionAug 22, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Adverse Event Without Identified Device or Use Problem; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Adverse Event Without Identified Device or Use Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ESC BUTTON HAD TO PRESS MORE THAN ONCE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM, PRIMING WAS MAKING A LOUD GRINDING NOISE, BATTERY LIFE WAS LASTING AROUND 2 WEEKS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920350 ↗
• MalfunctionMay 14, 2019Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS HAD TO PUSH MORE THAN ONCE, ALARMS WERE FAINT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT RESERVOIR PLASTIC CHIPPED OFF, CHANGING BATTERIES ONCE WITHIN 7 DAYS, REWIND PROCESS LONGER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607103 ↗
• MalfunctionApr 25, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 134 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8553417 ↗
• MalfunctionMar 25, 2019Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8447240 ↗
• MalfunctionFeb 7, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA CALL THAT THE TOP OF THE RESERVOIR COMPARTMENT WAS DAMAGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATE THAT NO LONGER HOLDS THE RESERVOIR. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319148 ↗
• MalfunctionDec 31, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CRACK ON INSULIN PUMP DUE TO WHICH CUSTOMER WAS UNABLE TO READ THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205781 ↗
• MalfunctionDec 24, 2018Device Alarm System; Device Difficult to Program or Calibrate; Material Integrity Problem; Device Alarm System; Device Difficult to Program or Calibrate; Material Integrity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE LESS RESPONSIVE AND INSULIN PUMP DID NOT ALARMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8193362 ↗
• MalfunctionDec 12, 2018Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE DIFFICULT TO SEE SCREEN. CUSTOMER ALSO STATED THAT THE BATTERY LIFE DIMINISHED AND BACK-LIGHT DIMINISHED. CUSTOMER TROUBLESHOOT WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8154352 ↗
• MalfunctionOct 23, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD REJECTED NEW BATTERY. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PRESS. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994528 ↗
• MalfunctionSep 27, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT THE BUTTONS WERE STICKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER ALSO STATED THAT THE LIGHTING ON THE PUMP SCREEN WAS DIM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916836 ↗
• MalfunctionSep 25, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905204 ↗
• MalfunctionSep 12, 2018Power Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE BATTERIES DIED AND INSULIN PUMP HAS A BLANK DISPLAY EVEN WHEN BATTERIES ARE REPLACED. TROUBLE SHOOTING OCCURRED TO TRY AND FIX THE PROBLEM BUT ISSUE REMAINS UNRESOLVED. BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT IS 110 MG/DL. NO SYMPTOMS REPORTED AND THEREFORE NO TREATMENT REQUIRED. PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867734 ↗
• MalfunctionAug 29, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE THAT INSULIN PUMP HAD FROZEN DISPLAY AND BEEPING CONTINUOUSLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 201 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE BUTTONS ON INSULIN PUMP WERE NOT RESPONDING. THE INSULIN PUMP WILL BE RETURNED BE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827387 ↗
• InjuryAug 5, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 489 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER HAD A HIGH BLOOD GLUCOSE OF 489 MG/DL AND NO FORM OF TREATMENT WAS REPORTED. NO HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7750156 ↗
• InjuryJun 23, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 425 MG/DL AT THE TIME OF INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL OF 200 MG/DL. THE CUSTOMER WAS TREATED WITH BOLUS. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7632446 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE LOW BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS ABOUT 47 MG/DL. OTHER RELEVANT BLOOD GLUCOSE VALUE OF THE CUSTOMER WAS 210 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7457275 ↗
• MalfunctionMar 1, 2018No Display/Image; Device Inoperable

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATES THAT THE PUMP WAS NOT WORKING, SHE RECEIVED A NEW BATTERY CAP, BUT THERE WAS BREAKAGE AROUND THE BATTERY CAP, CHANGED THE BATTERY AND NOW THE SCREEN WILL NOT COME BACK ON. TROUBLESHOOTING WAS PERFORMED FOR BLANK DISPLAY AND WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7306455 ↗
• InjuryFeb 6, 2018High Test Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 558 MG/DL AND CURRENT BLOOD GLUCOSE IS 389 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING ON INSULIN PUMP. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS WITH THE INSULIN PUMP. THE CUSTOMER WAS NEITHER HOSPITALIZED NOR ADMITTED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7245612 ↗
• MalfunctionJan 22, 2018Device Displays Incorrect Message

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALERT AND PRIME REWIND ANOMALY. THE BLOOD GLUCOSE WAS 157 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT, THE DRIVE SUPPORT CAP WAS FLUSHED. TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7210932 ↗
• MalfunctionDec 20, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 116MG/DL AND THE SENSOR GLUCOSE WAS 60MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7134339 ↗
• InjuryOct 27, 2017Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PATIENT¿S BLOOD GLUCOSE WAS LOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 53MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT TREATED WITH FOOD. AT LUNCH PATIENT¿S BLOOD GLUCOSE WAS 53MG/DL AND SENSOR GLUCOSE WAS 71MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6985477 ↗
• MalfunctionOct 17, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 235 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL (RECESSED). THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954945 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.

• Z-1751-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 530G Insulin Pump (MMT-551, MMT-751)
• Z-2544-2014 · Mar 13, 2014 · Terminated
  Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K